In a major advancement for India’s biotechnology sector, Union Minister for Science and Technology Dr. Jitendra Singh on Wednesday launched the country’s first indigenous antibiotic, Nafithromycin, developed to combat resistant infections.
The drug is awaiting final approval from the Central Drugs Standard Control Organization (CDSCO) for public use, marking a significant step in addressing Antimicrobial Resistance (AMR).
Developed with support from the Biotechnology Industry Research Assistance Council (BIRAC), a unit of the Department of Biotechnology, Nafithromycin is marketed under the trade name Miqnaf by Wockhardt Pharmaceuticals. It is specifically designed to treat Community-Acquired Bacterial Pneumonia (CABP), a severe infection caused by drug-resistant bacteria, which disproportionately affects vulnerable groups such as children, the elderly, and immune-compromised individuals like those with diabetes and cancer.
Dr. Singh hailed the three-day treatment regimen of Nafithromycin as a breakthrough in the battle against drug-resistant pneumonia, which causes over two million deaths globally each year. India, which accounts for 23% of the global pneumonia burden, has struggled with the growing resistance to drugs like azithromycin. Nafithromycin is claimed to be ten times more effective than current treatments, offering a faster, safer, and more tolerable option for patients.
This antibiotic is notable for its ability to target both typical and atypical pathogens, filling a crucial gap where no new antibiotics in this class have been developed in over three decades. It also boasts superior safety, with minimal gastrointestinal side effects, no significant drug interactions, and no food-related concerns, making it a versatile option for patients.
The launch of Nafithromycin marks the first new antibiotic of its kind in over 30 years, a critical milestone as AMR continues to threaten global health. Developed over 14 years and at a cost of Rs 500 crores, its clinical trials spanned India, the US, and Europe, underscoring India’s growing capabilities in biotechnology and pharmaceutical research.
This achievement is seen as a beacon of hope in the fight against multi-drug-resistant pathogens, with the potential to save countless lives worldwide. Prominent leaders from the scientific community including Rajesh S. Gokhale, Secretary, DBT and Chairman, BIRAC, Dr. Habil Khorakiwala, Chairman, Wockhardt, Dr. Jitendra Kumar, MD, BIRAC and Dr.YKGupta, President, AIIMS, Jammu were present at the event.
